Extension 1 to Protocol CSPP100A2340: Study to Evaluate the Efficacy and Safety of Aliskiren on the Prevention of Left Ventricular Remodeling in High Risk Post-Acute Myocardial Infarction Patients When Added to Optimized Standard Therapy

This study is currently recruiting participants.

Verified by Novartis, December 2008

First Received: June 9, 2008 Last Updated: December 5, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00699075

Purpose

The study will collect 2-year data on the safety of aliskiren and its effect on left ventricular remodeling in high-risk post-acute myocardial infarction (AMI) patients

Condition	Intervention	Phase
Myocardial Infarction	Drug: Aliskiren	Phase III

MedlinePlus related topics: Heart Attack

Drug Information available for: Aliskiren

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 2 Year Extension to a 36-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aliskiren on the Prevention of Left Ventricular Remodeling in High Risk Post-Acute Myocardial Infarction Patients When Added to Optimized Standard Therapy

Further study details as provided by Novartis:

Primary Outcome Measures:

Adverse events at each visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Echocardiography (left ventricular end systolic volume, left ventricular end diastolic volume, left ventricular ejection fraction) at 12 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Vital signs (blood pressure, heart rate) at each visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Laboratory evaluations at each visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
ECG at 12 and 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Aliskiren: Experimental 300 mg qd (tablet), oral, for 2 years	Drug: Aliskiren 300 mg qd (tablet), oral, for 2 years

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completion of 36-week double-blind treatment in study CSPP100A2340

Exclusion Criteria:

NYHA class IV congestive heart failure
Symptomatic hypotension
Estimated glomerular filtration rate < 30 ml/min/1.73m2
Pregnant or nursing (lactating) women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699075

Contacts

Contact: Novartis

(862) 778-8300

Show 25 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CSPP100A2340E1
Study First Received:	June 9, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00699075 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Canada: Health Products and Food Branch; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; United States: Food and Drug Administration; Venezuela: Ministry of Health and Social Development; India: Central Drugs Standard Control Organization; Korea: Food and Drug Administration; Belgium: Pharmaceutical Inspectorate; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: National Institute of Health; Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Netherlands: Medicines Evaluation Board (MEB); Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Ministry of Health

Keywords provided by Novartis:

Myocardial infarction, left ventricular dysfunction, echocardiography, aliskiren

Study placed in the following topic categories:

Ventricular Dysfunction
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ventricular Dysfunction, Left
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009